Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H-22073691 | Other Identifier | The Scientific Ethics Committee |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study evaluates the effectiveness of a supervised one-leg resistance training program in patients with inoperable lung cancer with the primary outcome being rate of force development.
Study design: Single center, two-armed, parallel-group, randomized controlled trial. The primary outcome being rate of force development after 12 weeks of progressive resistance training.
Muscular dysfunction and sarcopenia are known phenomena in cancer patients, and patients experience reduced muscle function and muscle loss regardless of cancer type or stage. Studies indicate that there are a number of cancer-specific and non-cancer-specific factors that influence muscle dysfunction, such as age, poor nutrition, physical inactivity, cancer pathology and treatment preparations. The decreased muscle function can ultimately lead to cachexia, typically seen in stage III - IV lung cancer patients.
Previous studies have focused on 1-RM tests, muscle mass and functionality as outcomes. However, a central aspect of functionality in lung cancer patients may be the muscle's ability to develop force in a short time. The present study therefore has rate of force development as a primary outcome with muscle mass and functionality as supporting outcomes. In addition, the patients in this study will perform one-leg resistance exercise with the other leg as the control leg. This will eliminate the interpersonal bias normally seen in randomized controlled trials.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Participants receive usual care | |
| Usual Care + exercise | Experimental | Participants receive usual care and one-leg resistance exercise training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistance training | Other | Supervised resistance training. 2 sessions/week for 12 weeks. The exercises are one-legged leg-press and one-leg knee extension. Resistance training start-up phase comprises 3 sets of 10 repetitions in each of the two exercises with 50% of 1RM. Resistance training progressive phase comprises 3 sets (leg-press) of 5-8 repetitions (70-90% 1 RM) and 6 sets (knee extension) of 8 repetition (75% 1RM). Rest between sets: 3 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle strength/function: Rate of Force Development (RFD) | The between group change in Rate of Force Development (Nm/s) of the knee extensors. Assessed in the CON-TREX MJ dynamometer. | Baseline, 6 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functionality: 6 minutes walk test (6-MWT) | Change in walking distance | Baseline, 6 weeks, 12 weeks |
| Lean leg mass | The between group change in lean leg mass (kg) assessed by whole-body dual-energy x-ray absorptiometry (DXA) scan |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Morten Quist, ph.d. | Contact | +4535457335 | +4523467919 | morten.quist@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Morten Quist, ph.d. | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Copenhagen | Recruiting | København Ø | Please Select | 2100 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009043 | Motor Activity |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
Not provided
Not provided
Parallel assignment. The participants will be randomized to either left or right leg resistance training.
Not provided
Not provided
Not provided
|
| Baseline, 6 weeks, 12 weeks |
| Functionality: Postural balance | Postural one-leg balance on a 5-cm high, 3-cm wide, and 50-cm long plastic bar. Between group change in number of times the participants steps off the bar or needs support to prevent falling in a period of 1 min. | Baseline, 6 weeks, 12 weeks |
| Functionality: Sit-to-stand (30s STS) | Change in sit-to-stand in 30 seconds | Baseline, 6 weeks, 12 weeks |
| Functionality: Sit-to-stand (5reps STS) | Change in time for 5 STS repetitions | Baseline, 6 weeks, 12 weeks |
| Muscle strength/function: 1 RM | The between group change in 1 repetition maximum in knee-extension and leg-press | Baseline, 6 weeks, 12 weeks |
| Muscle strength/function: Power | The between group change in maximum isometric knee extension power (Nm). Assessed in the CON-TREX MJ dynamometer. | Baseline, 6 weeks, 12 weeks |
| Muscle strength/function: Isokinetic strength | The between group change in maximum isokinetic knee extension power (Nm) (60 degrees/s). Assessed in the CON-TREX MJ dynamometer. | Baseline, 6 weeks, 12 weeks |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |