Trial Outcomes & Findings for Home-Based Exercise and Weight Control Program for Pain Control in Overweight Elderly With Osteoarthritis of the Knee (NCT NCT00126737)

Last Updated: 2015-01-01

Results Overview

Western Ontario and McMaster University Osteoarthritis Index (WOMAC) is used to measure pain, function, and stiffness in patients with OA of the knee. At 24 weeks post-baseline, the average change in score was measured. We used the Function Scale only for this study. The Function Scale has 17 items, the responses are in Likert scale; namely 0=No difficulty, 1=Slight, 2=Moderate, 3= Very, 4=Extremely. The total score ranges from 0 to 68, a higher score means worse functioning. A score of 68 indicates extremely difficult in functioning.

Recruitment status

COMPLETED

Study phase

Target enrollment

110 participants

Primary outcome timeframe

Between Base-line and 24 weeks

Results posted on

2015-01-01

Participant Flow

The study sample was recruited from the general medicine and arthritis clinics of VA Hospital Hines, Illinois, and several non-VA affiliated community-based clinics.

143 subjects were screened for eligibility in the study. 33 subjects were excluded; reasons for exclusion: 7 = cardiovascular (CV) , 3 = hospitalized, 1= knee surgery, 6 = no transport, 5 = impaired cognition, 4 = spouse illness, 4= moved, and 3 = disagree with assignment/not interested. 110 subjects were then randomized.

Participant milestones

Participant milestones
Measure	Weight Control Nutritional and Home-based Exercise Program Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC). Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises	Weight Control Nutritional Program Group assigned to a Weight Control Nutritional Program (WC). Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables.	Home-based Exercise Program Group assigned to a home-based exercise program (Ex). Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.	Usual Care Usual care and non-specific health information (C). No intervention.
Overall Study STARTED	28	27	30	25
Overall Study COMPLETED	22	24	24	18
Overall Study NOT COMPLETED	6	3	6	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Home-Based Exercise and Weight Control Program for Pain Control in Overweight Elderly With Osteoarthritis of the Knee

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Weight Control Nutritional and Home-based Exercise Pro n=28 Participants Group assigned to both a Weight Control Nutritional Program and home-based exercise Program (Ex+WC). Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.	Weight Control Nutritional Program n=27 Participants Group assigned to a Weight Control Nutritional Program (WC). Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables.	Home-based Exercise Program n=30 Participants Group assigned to a Home-based exercise program (Ex). Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.	Usual Care n=25 Participants Usual care and non-specific health information (C). No intervention.	Total n=110 Participants Total of all reporting groups
Age, Continuous	70.3 years STANDARD_DEVIATION 9.6 • n=5 Participants	66.3 years STANDARD_DEVIATION 7.3 • n=7 Participants	65.8 years STANDARD_DEVIATION 7.6 • n=5 Participants	69.5 years STANDARD_DEVIATION 8.5 • n=4 Participants	67.9 years STANDARD_DEVIATION 8.4 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	11 Participants n=21 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	25 Participants n=7 Participants	27 Participants n=5 Participants	24 Participants n=4 Participants	99 Participants n=21 Participants
Race/Ethnicity, Customized White	24 participants n=5 Participants	23 participants n=7 Participants	28 participants n=5 Participants	24 participants n=4 Participants	99 participants n=21 Participants
Race/Ethnicity, Customized Non-white	4 participants n=5 Participants	4 participants n=7 Participants	2 participants n=5 Participants	1 participants n=4 Participants	11 participants n=21 Participants
BMI at Baseline	33.8 kg/m^2 STANDARD_DEVIATION 6.4 • n=5 Participants	36.8 kg/m^2 STANDARD_DEVIATION 6.2 • n=7 Participants	34.3 kg/m^2 STANDARD_DEVIATION 5.4 • n=5 Participants	32.8 kg/m^2 STANDARD_DEVIATION 5.1 • n=4 Participants	34.4 kg/m^2 STANDARD_DEVIATION 5.9 • n=21 Participants
Duration of OA	9.1 years STANDARD_DEVIATION 10.4 • n=5 Participants	9.4 years STANDARD_DEVIATION 6.0 • n=7 Participants	11.5 years STANDARD_DEVIATION 13.2 • n=5 Participants	10.0 years STANDARD_DEVIATION 9.8 • n=4 Participants	10.0 years STANDARD_DEVIATION 10.1 • n=21 Participants
Walking Distance	414.9 meters STANDARD_DEVIATION 92.6 • n=5 Participants	445.1 meters STANDARD_DEVIATION 125.4 • n=7 Participants	476.9 meters STANDARD_DEVIATION 101.4 • n=5 Participants	435.1 meters STANDARD_DEVIATION 82.4 • n=4 Participants	443.8 meters STANDARD_DEVIATION 102.7 • n=21 Participants
WOMAC Function	44.0 Score STANDARD_DEVIATION 11.4 • n=5 Participants	39.2 Score STANDARD_DEVIATION 12.0 • n=7 Participants	40.3 Score STANDARD_DEVIATION 10.6 • n=5 Participants	44.4 Score STANDARD_DEVIATION 14.8 • n=4 Participants	41.9 Score STANDARD_DEVIATION 12.2 • n=21 Participants
36 Items Short Form Survey Instrument (SF-36v) Mental Scale	52.1 score STANDARD_DEVIATION 10.6 • n=5 Participants	51.9 score STANDARD_DEVIATION 9.8 • n=7 Participants	48.2 score STANDARD_DEVIATION 11.4 • n=5 Participants	48.3 score STANDARD_DEVIATION 11.5 • n=4 Participants	50.1 score STANDARD_DEVIATION 10.8 • n=21 Participants
SF-36v Physical Scale	34.7 score STANDARD_DEVIATION 7.8 • n=5 Participants	41.1 score STANDARD_DEVIATION 7.2 • n=7 Participants	35.7 score STANDARD_DEVIATION 8.2 • n=5 Participants	36.4 score STANDARD_DEVIATION 9.0 • n=4 Participants	36.9 score STANDARD_DEVIATION 8.3 • n=21 Participants
Stair Total (climb, descend)	167.7 stairs STANDARD_DEVIATION 52.5 • n=5 Participants	181.0 stairs STANDARD_DEVIATION 53.2 • n=7 Participants	182.9 stairs STANDARD_DEVIATION 54.1 • n=5 Participants	171.7 stairs STANDARD_DEVIATION 52.8 • n=4 Participants	176.0 stairs STANDARD_DEVIATION 52.8 • n=21 Participants
Married Married	13 participants n=5 Participants	18 participants n=7 Participants	20 participants n=5 Participants	16 participants n=4 Participants	67 participants n=21 Participants
Married Not-Married	15 participants n=5 Participants	9 participants n=7 Participants	10 participants n=5 Participants	9 participants n=4 Participants	43 participants n=21 Participants

PRIMARY outcome

Timeframe: Between Base-line and 24 weeks

Population: There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 2 in Weight control Nutritional and home -based Exercise program, 3 in Weight Control Nutritional Program, 1 in Home-based exercise program and 1 in Usual Care.

Outcome measures

Outcome measures
Measure	Weight Control Nutritional and Home-based Exercise Pro n=20 Participants Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC). Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.	Weight Control Nutritional Program n=21 Participants Group assigned to a Weight Control Nutritional Program (WC). Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables.	Home-based Exercise Program n=23 Participants Group assigned to a home-based exercise program (Ex). Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.	Usual Care n=17 Participants Usual care and non-specific health information (C). No intervention.
WOMAC Function	-10.4 Change in Score Interval -15.4 to -5.0	-4.8 Change in Score Interval -8.7 to -0.9	-4.9 Change in Score Interval -7.8 to -2.0	-1.6 Change in Score Interval -9.0 to 5.8

PRIMARY outcome

Timeframe: Between Base-line and 24 weeks

Population: There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 1 in Weight control Nutritional and home -based Exercise program, 3 in Weight Control Nutritional Program, 3 in the Usual Care.

The Rand Short Form-36 (SF-36) was used to measure health related quality of life (i.e. physical health). The average change in score 24 weeks post-baseline was measured. Physical Health consists of 4 scales, Physical Function (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items). The Physical Health component is a summary measure of scales, and the scores ranges from 0 to 100, a score of 50 is the normative average of general health. Lower scores correspond to worse physical health, higher scores correspond to better physical health.

Outcome measures

Outcome measures
Measure	Weight Control Nutritional and Home-based Exercise Pro n=21 Participants Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC). Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.	Weight Control Nutritional Program n=21 Participants Group assigned to a Weight Control Nutritional Program (WC). Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables.	Home-based Exercise Program n=24 Participants Group assigned to a home-based exercise program (Ex). Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.	Usual Care n=15 Participants Usual care and non-specific health information (C). No intervention.
Physical Scale SF-36v	5.51 Change in score Interval 1.38 to 9.88	0.56 Change in score Interval -2.32 to 3.44	3.58 Change in score Interval -0.83 to 8.0	0.34 Change in score Interval -4.19 to 4.88

PRIMARY outcome

Timeframe: Between Base-line and 24 weeks

The Rand Short Form-36 (SF-36) was used to measure health related quality of life (i.e. mental health). The average change in score 24 weeks post-baseline was measured. Mental Health component consisted of 4 scales; these are the scales: Vitality ( 4 items), Social functioning (2 items), Role Emotional (3 items), and Mental Health (5 items). The mental health summary measures is called the Mental health component of SF36v. It was used to measure health related quality of life (i.e. mental health). The total score ranged from 0 to 100, a score of 50 is the normative average for general mental health. Lower scores correspond to worse mental health status, higher scores correspond to better mental health status.

Outcome measures

Outcome measures
Measure	Weight Control Nutritional and Home-based Exercise Pro n=21 Participants Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC). Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.	Weight Control Nutritional Program n=21 Participants Group assigned to a Weight Control Nutritional Program (WC). Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables.	Home-based Exercise Program n=24 Participants Group assigned to a home-based exercise program (Ex). Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.	Usual Care n=15 Participants Usual care and non-specific health information (C). No intervention.
Mental Scale SF-36v	0.28 Change in Score Interval -3.57 to 4.12	2.62 Change in Score Interval -1.11 to 6.35	-0.23 Change in Score Interval -3.25 to 2.8	-2.64 Change in Score Interval -8.16 to 2.88

SECONDARY outcome

Timeframe: Between Base-line and 24 weeks

Average distance walked in six minutes. The average change in distance walked (meters) 24 weeks post-baseline was measured.

Outcome measures

Outcome measures
Measure	Weight Control Nutritional and Home-based Exercise Pro n=21 Participants Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC). Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.	Weight Control Nutritional Program n=22 Participants Group assigned to a Weight Control Nutritional Program (WC). Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables.	Home-based Exercise Program n=24 Participants Group assigned to a home-based exercise program (Ex). Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.	Usual Care n=18 Participants Usual care and non-specific health information (C). No intervention.
Walking Distance	71.64 Change in Distance (m) Interval 46.04 to 97.24	17.42 Change in Distance (m) Interval -12.4 to 47.25	42.08 Change in Distance (m) Interval 19.84 to 64.32	6.55 Change in Distance (m) Interval -29.73 to 42.82

SECONDARY outcome

Timeframe: Between Base-line and 24 Weeks

Population: There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 2 in Weight control Nutritional and home -based Exercise program, 1 in Weight Control Nutritional Program, 1 in Home-based exercise Program and 1 in Usual Care.

Total amount of stairs climbed and descended for three minutes. Subjects climbed four steps up and descended four steps down. The average change in total number of steps 24 weeks post-baseline was measured.

Outcome measures

Outcome measures
Measure	Weight Control Nutritional and Home-based Exercise Pro n=20 Participants Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC). Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.	Weight Control Nutritional Program n=23 Participants Group assigned to a Weight Control Nutritional Program (WC). Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables.	Home-based Exercise Program n=23 Participants Group assigned to a home-based exercise program (Ex). Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.	Usual Care n=17 Participants Usual care and non-specific health information (C). No intervention.
Stair Total (Climb, Descend)	39.75 Change in Steps Interval 28.78 to 50.72	23.61 Change in Steps Interval 8.51 to 38.71	40.48 Change in Steps Interval 25.82 to 55.14	9.06 Change in Steps Interval -10.24 to 28.36

Adverse Events

Weight Control Nutritional and Home-based Exercise Pro

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Weight Control Nutritional Program

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Home-based Exercise Program

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Weight Control Nutritional and Home-based Exercise Pro n=28 participants at risk Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC). Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.	Weight Control Nutritional Program n=27 participants at risk Group assigned to a Weight Control Nutritional Program (WC). Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables.	Home-based Exercise Program n=30 participants at risk Group assigned to a Home-based exercise program (Ex). Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.	Usual Care n=25 participants at risk Usual Care and non-specific health information (C). No intervention.
Musculoskeletal and connective tissue disorders Knee Pain	0.00% 0/28 • 24 weeks.	0.00% 0/27 • 24 weeks.	6.7% 2/30 • Number of events 2 • 24 weeks.	0.00% 0/25 • 24 weeks.
Cardiac disorders Atrial Fibrillation	7.1% 2/28 • Number of events 2 • 24 weeks.	0.00% 0/27 • 24 weeks.	0.00% 0/30 • 24 weeks.	0.00% 0/25 • 24 weeks.
Respiratory, thoracic and mediastinal disorders COPD	3.6% 1/28 • Number of events 1 • 24 weeks.	0.00% 0/27 • 24 weeks.	0.00% 0/30 • 24 weeks.	4.0% 1/25 • Number of events 1 • 24 weeks.
General disorders Chest Pain	0.00% 0/28 • 24 weeks.	7.4% 2/27 • Number of events 2 • 24 weeks.	3.3% 1/30 • Number of events 1 • 24 weeks.	8.0% 2/25 • Number of events 2 • 24 weeks.
Respiratory, thoracic and mediastinal disorders Pneumonia	7.1% 2/28 • Number of events 2 • 24 weeks.	0.00% 0/27 • 24 weeks.	0.00% 0/30 • 24 weeks.	0.00% 0/25 • 24 weeks.
Cardiac disorders CAD	3.6% 1/28 • Number of events 1 • 24 weeks.	0.00% 0/27 • 24 weeks.	0.00% 0/30 • 24 weeks.	0.00% 0/25 • 24 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Abscess	0.00% 0/28 • 24 weeks.	0.00% 0/27 • 24 weeks.	3.3% 1/30 • Number of events 1 • 24 weeks.	0.00% 0/25 • 24 weeks.
Psychiatric disorders Confusion	0.00% 0/28 • 24 weeks.	0.00% 0/27 • 24 weeks.	3.3% 1/30 • Number of events 1 • 24 weeks.	0.00% 0/25 • 24 weeks.
Gastrointestinal disorders Cholecystitis	0.00% 0/28 • 24 weeks.	0.00% 0/27 • 24 weeks.	3.3% 1/30 • Number of events 1 • 24 weeks.	0.00% 0/25 • 24 weeks.
Social circumstances Moved	0.00% 0/28 • 24 weeks.	3.7% 1/27 • Number of events 1 • 24 weeks.	3.3% 1/30 • Number of events 1 • 24 weeks.	0.00% 0/25 • 24 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.00% 0/28 • 24 weeks.	0.00% 0/27 • 24 weeks.	0.00% 0/30 • 24 weeks.	4.0% 1/25 • Number of events 1 • 24 weeks.
Gastrointestinal disorders Diverticulitis	0.00% 0/28 • 24 weeks.	0.00% 0/27 • 24 weeks.	0.00% 0/30 • 24 weeks.	4.0% 1/25 • Number of events 1 • 24 weeks.
Immune system disorders Allergy	0.00% 0/28 • 24 weeks.	0.00% 0/27 • 24 weeks.	0.00% 0/30 • 24 weeks.	4.0% 1/25 • Number of events 1 • 24 weeks.
Social circumstances Not Interested	0.00% 0/28 • 24 weeks.	0.00% 0/27 • 24 weeks.	0.00% 0/30 • 24 weeks.	4.0% 1/25 • Number of events 1 • 24 weeks.

Additional Information

Elly Budiman-Mak, MS MPH MD

Edward Hines, Jr. VA Hospital

Phone: 708-202-2414

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place